BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23800486 · Received December 15, 2025

    Report

    Report Number
    2016493-2025-143367
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 5, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 23-JUL-2024 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT NETWORK INTERFACE ERROR APPEARED ON THE HOME SCREEN. A FIELD SERVICE ENGINEER INSPECTED THE STATION AND ENTERED SUPPORT MODE, CONFIRMING THAT NO NETWORK CONNECTIONS WERE PRESENT IN THE NETWORK SETTINGS. THE ENGINEER REPLACED THE ALL-IN-ONE COMPONENT FOR THE STATION WITH AN ALL-IN-ONE FROM AN UNUSED STATION IN STORAGE. AFTER REBOOTING THE STATION INTO SUPPORT MODE, THE ENGINEER VERIFIED THAT NETWORK SETTINGS WERE RESTORED, CONFIGURED THE MEDICATION LABEL MANAGEMENT (MLM) PRINTER FOR THE CUSTOMER, AND REBOOTED THE STATION INTO THE APPLICATION. THE STATION COMMUNICATED WITH THE SERVER SUCCESSFULLY, AND THE MLM PRINTER WORKED PROPERLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, HAD AN INTERFACE ERROR AND WAS UNABLE TO LOGIN. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735356 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown